Accelerated iTBS for Depression: Monitoring Brain Hemodynamics With Simultaneous iTBS/fNIRS

NCT06971549 | Recruiting

• 1 other identifier: HSEARS20230705001-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the cortical hemodynamic response variability of an accelerated form of TBS stimulation over left dorsolateral prefrontal cortex (DLPFC) using a concurrent TBS/fNIRS setup. The accelerating TMS protocol that will be used in this study is similar to the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), i.e., fifty iTBS sessions (1,800 pulses per session, 50-minute intersession interval) will be delivered as 10 daily sessions over 5 consecutive days at 90% resting motor threshold. The investigators will recruit a depressed patient and conduct a concurrent iTBS/fNIRS protocol for each iTBS session. Moreover, the depression symptoms of the patient will be assessed before and after treatment.

Conditions

Depression

Keywords

Theta-Burst stimulation (iTBS); Functional near-infrared spectroscopy (fNIRS); Concurrent TMS/fNIRS; Prefrontal hemodynamic response

Outcome Measures

Primary Outcomes (2)

• Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline

  iTBS-induced HbO and HbR change in the DLPFC before, during and after stimulation

  Before, during and immediately after the intervention

• Hamilton Depression Rating Scale (HAM-D)

  The Hamilton Depression Rating Scale, 17 item (HAM-D-17) is a simple, clinician-administered tool used to assess symptoms of depression experienced by a patient in the past week. The values of HAM-D-17 range from 0 to 52, and higher socres mean more severe symptoms.

  through study completion, an average of 5 days

Secondary Outcomes (3)

• Montgomery-Asberg depression rating scale (MADRS)

  through study completion, an average of 5 days

• Patient Health Questionnaire-9 (PHQ-9)

  daily for 5 days

• Verbal Analogue Scale (VAS) fatigue and pain level

  immediately after the intervention

Study Arms (1)

Accelerating TMS teatment

EXPERIMENTAL

One depressed patient will be included in this study, which lasts for 5 consecutive days. During these 5 days, the participant will receive accelerated TMS treatment based on SAINT protocol, simultaneously monitored by concurrent TMS/fNIRS.

Other: Accelerated iTBS

Interventions

Accelerated iTBS OTHER

Fifty iTBS sessions (1,800 pulses per session, 50-minute intersession interval) will be delivered as 10 daily sessions over 5 consecutive days at 90% resting motor threshold.

Accelerating TMS teatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 to 65;
• a clinical diagnosis of current nonpsychotic major depressive disorder by an experienced psychiatrist according to DSM-IV;
• no or stable (≥2 weeks) psychopharmacological medication;
• have not responded to at least one antidepressant medication;
• have not received any TMS treatment;
• and have a 17-item HAMD score ≥ 20.

You may not qualify if:

• severe internal diseases;
• neurological disorders or a history of severe head injuries;
• having suicidal ideation;
• pregnancy;
• antiepileptics and benzodiazepines corresponding to a dose of \>1 mg lorazepam/d.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Georg Kranz, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg Kranz, PhD

CONTACT

27664838; georg.kranz@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 14, 2025
• Study Start: March 19, 2025
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)